The most common cause of anemia is iron deficiency, which occurs in both men and women. This may result from gastrointestinal blood loss due to drug therapy (often in the case of use of aspirin and non-steroidal anti-inflammatory drugs). In adolescents, rapid growth may outpace dietary intake of iron, and result in iron deficiency anemia without disease or grossly abnormal diet. In women of childbearing age, heavy or long menstrual periods can also cause iron deficiency anemia.
Without iron supplementation, iron deficiency anemia occurs in many pregnant women because their iron stores need to serve their own increased blood volume as well as be a source of hemoglobin for the growing fetus. While minerals and vitamins can be obtained through diet, it is known that less than 10% of average Americans consume a nutritious diet sufficient to supply these materials. This can, with respect to pregnant women, increase the risk of maternal and/or fetal mortality, premature delivery and low birth weight, and other associated complications, both before and after delivery.
Especially in adults over the age of 50, iron deficiency anemia is often a sign of other diseases in the gastrointestinal tract, such as chronic bleeding from any cause (for example, a colon cancer) that causes loss of blood in the stool. Such loss is often undetectable, except with special testing. In adults, 60% of patients with iron deficiency anemia have underlying gastrointestinal disorders leading to chronic blood loss, and this percentage increases with patient age.
Iron deficiency anemia also affects people having chronic diseases, such as kidney disease, inflammatory bowel disease, cancer, HIV, and diabetes.
Many supplements called hemetinics have been proposed and/or are currently being marketed in the United States to overcome the iron deficiency anemia. See, for example, Helenek et al. U.S. Pat. No. 7,754,702; Venkataraman et al. U.S. Pat. No. 7,785,527 and U.S. Pat. No. 8,080,520; Nidamarty et al. U.S. Pat. No. 7,994,217; Connor et al. U.S. Pat. No. 8,071,542; and Nelson et al. U.S. Pat. No. 8,178,709. Prenatal supplements with iron are described in Morrison et al. U.S. Pat. No. 7,964,189 and U.S. Pat. No. 8,454,951. Heme-iron for example, while highly bioavailable from meat and animal products, is not always the best option for iron supplementation. However, commonly used forms of non-heme iron (from sources like vegetables and iron supplements), cause gastrointestinal distress, which undermines individual or patient compliance. While ingredients used in currently available supplements may not do any harm, in the sense that the body will eliminate in one way or another that which is not needed, there is a preference, and it is our desire, to set forth unique nutritional supplement that have those, and only those, ingredients that serve necessary and beneficial purposes related to treating iron deficiency anemia.